Implant-cinching devices and systems

ABSTRACT

An annuloplasty implant comprises an elongate member, a plurality of anchors, and a gripper. The elongate member has a proximal end, and a distal portion that includes a distal end. The plurality of anchors are distributed along the elongate member. The elongate member extends proximally from a proximal-most anchor and through the gripper. The gripper comprises a locking element that, in a locked state, inhibits sliding of the elongate member through the gripper. An unlocker, disposed within the gripper, obstructs the locking element from assuming the locked state, and is pullable proximally out of the gripper. The gripper automatically assumes the locked state upon the unlocker being pulled proximally out of the gripper. A tool tensions the distal portion of the elongate member by pulling the elongate member proximally through the gripper while the unlocker obstructs the locking element from assuming the locked state. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. Ser. No. 16/154,233 toSheps et al., filed Oct. 8, 2018, and entitled “Implant-cinching devicesand systems;” which claims priority from U.S. Provisional application62/580,646 to Sheps et al., filed Nov. 2, 2017, and entitled“Implant-cinching devices and systems.”

Each of the above applications is incorporated herein by reference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general toadjustment of an implant. For example, some applications of the presentinvention relate to contraction of a cardiovascular implant.

BACKGROUND

Ischemic heart disease can cause valve regurgitation, such as mitralregurgitation by the combination of ischemic dysfunction of thepapillary muscles, and the dilatation of the left ventricle that ispresent in ischemic heart disease, with the displacement of thepapillary muscles and the dilatation of the mitral valve annulus.

Dilation of the annulus of the mitral valve (or another valve) canprevent the valve leaflets from fully coapting when the valve is closed.Mitral regurgitation of blood from the left ventricle into the leftatrium results in increased total stroke volume and decreased cardiacoutput, and ultimate weakening of the left ventricle secondary to avolume overload and a pressure overload of the left atrium.

Dilation of other regions of the heart, vascular system, and/or othervalve annuluses can also result in similar problems, includingregurgitation at other valves.

Annuloplasty, such as by implantation of an annuloplasty ring or otherannuloplasty device, can be used to improve leaflet coaptation byadjusting the shape of a native valve annulus, e.g., the mitral annulus,tricuspid annulus, etc.

SUMMARY OF THE INVENTION

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures described can be combined in a variety of ways. The descriptionherein relates to systems, assemblies, methods, devices, apparatuses,combinations, etc. that may be utilized for cinching, tightening,tensioning a medical implant. Various features and steps as describedelsewhere in this disclosure may be included in the examples summarizedhere.

As one example, an adjustment system can include an elongate member. Theelongate member can enter into a pouch (e.g., an elastic pouch) at afirst part of the pouch, extend through the pouch, and can be connectedto a second part of the pouch. The system and its components can beconfigured such that stretching of the pouch (e.g., elasticallystretching the pouch) causes a distance between the first and secondparts of the pouch to increase, thereby drawing more of the elongatemember into the pouch. The system can include a gripper. The gripper canbe disposed at the first part of the pouch, and can be configured suchthat it can inhibit the elongate member from re-exiting the pouch whenthe pouch is allowed to re-contract. Therefore, the net result ofstretching and releasing the pouch can be reduction of a length of theelongate member that is disposed outside of the pouch.

The elongate member can be attached to or be part of an implant orimplant body in a manner that changes a dimension of the implant orimplant body when the length of the elongate member that is disposedoutside of the pouch is reduced. For some applications, the implant orimplant body includes a sleeve that is longitudinally contracted whenthe length of the elongate member that is disposed outside of the pouchis reduced. For some such applications, the implant or implant body canbe an annuloplasty ring structure, other annuloplasty device structure,or other cinchable/tensionable structure, anchored to the native valveannulus (e.g., mitral valve annulus, tricuspid valve annulus, etc.), andlongitudinal contraction of the sleeve contracts the native valveannulus. The implant or implant body can have an open or closed (e.g., aclosed ring) configuration and can be configured for transvascular ortranscatheter implantation and/or surgical implantation.

A system or apparatus for tightening, cinching, or tensioning caninclude one or more of a gripper, an elastic pouch, and an elongatemember. The elastic pouch can have a first part and a second part. Thefirst part can be coupled to the gripper. The elastic pouch can bestretchable into a stretched state in which the pouch defines astretched distance between the first part and the second part. Theelastic pouch can also have a contracted state toward which the pouch iselastically biased, and in which the pouch defines a contracted distancebetween the first part and the second part, the contracted distancebeing smaller than the stretched distance. In at least one state of thegripper, the elongate member can be slidable through the gripper andinto the pouch.

The system or apparatus above and/or another similar system or apparatuscan include one or more of an implant having an implant body, a gripper,coupled to the implant body, an elastic pouch, and an elongate member.The elastic pouch can be coupled to the gripper, have a first part and asecond part, be reversibly stretchable into a stretched state in whichthe pouch defines a stretched distance between the first part and thesecond part, and/or have a contracted state toward which the pouch iselastically biased, and in which the pouch defines a contracted distancebetween the first part and the second part, the contracted distancebeing smaller than the stretched distance.

The elongate member can have a first end portion coupled to the implantbody, a second end portion fastened to the second part of the pouch, anda third portion or a mid-portion extending (i) from the second endportion, through the pouch to the first part of the pouch, and (ii) outof the pouch to the first end portion. In at least one state of thegripper, the third portion or mid-portion can be slidable through thegripper and into the pouch.

In an application, the implant or implant body can include anannuloplasty ring structure, other annuloplasty device structure, orother cinchable/tensionable structure.

In an application, the gripper includes a plurality of teeth thatprovide a gripping surface configured to grip the elongate member.

In an application, the pouch is coupled to the gripper by the first partof the pouch being coupled to the gripper.

In an application, the first part of the pouch defines an opening intothe pouch, and in the at least one state of the gripper, the thirdportion or mid-portion in slidable through the gripper and into thepouch via the opening.

In an application, in at least one state of the gripper, the gripperinhibits sliding of the third portion or mid-portion through the gripperand out of the pouch.

In an application, the at least one state of the gripper includes aunidirectional state in which the gripper facilitates sliding of thethird portion or mid-portion through the gripper in a first directionthat is into the pouch, and inhibits sliding of the third portion ormid-portion through the gripper in a second, opposite direction that isout of the pouch.

In an application, the gripper has an unlocked state in which thegripper facilitates sliding of the third portion or mid-portion throughthe gripper in the first direction and in the second direction.

In an application, the gripper includes one or more wheels that, in theunidirectional state, grip the third portion or mid-portion, each of theone or more wheels configured to rotate in only one rotationaldirection.

In an application, the at least one state of the gripper includes:

an unlocked state in which the gripper facilitates sliding of the thirdportion or mid-portion through the gripper in a first direction that isinto the pouch, and in a second, opposite direction that is out of thepouch, and

a locked state in which the gripper inhibits sliding of the thirdportion or mid-portion through the gripper in the first direction and inthe second direction.

In an application, the apparatus further includes an unlocker,configured to actuate the gripper to transition between the unlockedstate and the locked state.

In an application, the unlocker is configured to maintain the gripper inthe unlocked state, the gripper being configured to automaticallytransition into the locked state upon removal of the unlocker from thegripper.

In an application, the unlocker includes a filament, reversibly coupledto the unlocker, and wherein tensioning of the filament transitions thegripper to the unlocked state.

In an application, the unlocker is configured to reversibly actuate thegripper to transition repeatedly between the unlocked state and thelocked state.

In an application, the gripper includes a jaw that, in the locked state,clamps onto the third portion or mid-portion, and the unlocker maintainsthe gripper in the unlocked state by inhibiting the jaw from clampingonto the third portion or mid-portion.

In an application:

the gripper includes a jaw that, in the locked state, clamps onto thethird portion or mid-portion, and

the unlocker includes a filament (e.g., a suture or wire), reversiblycoupled to the jaw such that tensioning of the filament transitions thegripper into the unlocked state by pulling the jaw away from the thirdportion or mid-portion.

In an application:

the apparatus further includes a guide member that defines the unlockerat a distal end of the guide member,

the apparatus further includes an adjustment-facilitating tool thatincludes a tensioning element that is reversibly couplable to the pouch,such that while coupled to the pouch, application of aproximally-directed force to the tensioning element stretches the pouchinto its stretched state, and

the adjustment-facilitating tool is advanceable along the guide memberto the implant subsequent to implantation of the implant.

In an application, the apparatus further includes anadjustment-facilitating tool that includes a tensioning element that isreversibly couplable to the pouch, such that while coupled to the pouch,application of a proximally-directed force to the tensioning elementstretches the pouch into its stretched state.

In an application, the apparatus further includes a guide member,reversibly coupled to the implant, and the adjustment-facilitating toolis advanceable along the guide member to the implant subsequent toimplantation of the implant.

In an application, the adjustment-facilitating tool further includes apressing element, slidably coupled to the tensioning element such that,while the tensioning element is coupled to the pouch, application of adistally-directed force to the pressing element presses the pressingelement against the implant.

In an application, the pressing element maintains coupling between thetensioning element and the pouch, and withdrawal of the pressing elementdecouples the tensioning element from the pouch.

In an application, the pressing element is disposed coaxially around thetensioning element.

In an application, the tensioning element is disposed coaxially aroundthe pressing element.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against the implant body.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against the gripper.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against an inner surface of thepouch.

In an application, the implant further includes a coupling that isattached to the pouch, and to which the adjustment-facilitating tool isreversibly couplable.

In an application, stretching of the pouch into the stretched statecontracts the implant body.

In an application, the implant body includes a fabric sleeve thatdefines a circumferential wall that defines a lumen, the elongate memberextends along the sleeve to where the first end portion of the elongatemember is coupled to the sleeve, and stretching of the pouch into thestretched state longitudinally contracts the sleeve.

In an application, the apparatus further includes a plurality ofanchors, and each anchor of the plurality of anchors:

includes a tissue-coupling element and a tool-engaging head fastened toone end of the tissue-coupling element, and

is configured to be intracorporeally delivered into the lumen of thesleeve, and to anchor the sleeve to the tissue of the subject by thetissue-coupling element being driven through the circumferential walland into the tissue.

In one embodiment, a system or apparatus can include one or more of animplant, a gripper, an elastic pouch, and an elongate member. Theelastic pouch can have a first part and a second part, the first partbeing coupled to the gripper. The elastic pouch can be reversiblystretchable into a stretched state in which the pouch defines astretched distance between the first part and the second part. Theelastic pouch can have a contracted state toward which the pouch iselastically biased, and in which the pouch defines a contracted distancebetween the first part and the second part, the contracted distancebeing smaller than the stretched distance. In at least one state of thegripper, the elongate member is slidable through the gripper and intothe pouch. The elongate member can have an end portion that is fastenedto the second part of the pouch, such that, in at least the one state ofthe gripper, stretching of the pouch into the stretched state pulls theelongate member through the gripper and into the pouch.

In an application, the gripper includes a plurality of teeth thatprovide a gripping surface configured to grip the elongate member.

In an application, the first part of the pouch defines an opening intothe pouch, and in the at least one state of the gripper, the elongatemember in slidable through the gripper and into the pouch via theopening.

In an application, in at least one state of the gripper, the gripperinhibits sliding of the elongate member through the gripper and out ofthe pouch.

In an application, the at least one state of the gripper includes aunidirectional state in which the gripper facilitates sliding of theelongate member through the gripper in a first direction that is intothe pouch, and inhibits sliding of the elongate member through thegripper in a second, opposite direction that is out of the pouch.

In an application, the gripper has an unlocked state in which thegripper facilitates sliding of the elongate member through the gripperin the first direction and in the second direction.

In an application, the gripper includes one or more wheels that, in theunidirectional state, grip the elongate member, each of the one or morewheels configured to rotate in only one rotational direction.

In an application, the at least one state of the gripper includes:

an unlocked state in which the gripper facilitates sliding of theelongate member through the gripper in a first direction that is intothe pouch, and in a second, opposite direction that is out of the pouch,and

a locked state in which the gripper inhibits sliding of the elongatemember through the gripper in the first direction and in the seconddirection.

In an application, the apparatus further includes an unlocker,configured to maintain the gripper in the unlocked state, the gripperconfigured to automatically transition into the locked state uponremoval of the unlocker from the gripper.

In an application, the gripper includes a jaw that, in the locked state,clamps onto the elongate member, and the unlocker maintains the gripperin the unlocked state by inhibiting the jaw from clamping onto theelongate member.

In an application:

the apparatus further includes a guide member that defines the unlockerat a distal end of the guide member,

the apparatus further includes an adjustment-facilitating tool thatincludes a tensioning element that is reversibly couplable to the pouch,such that while coupled to the pouch, application of aproximally-directed force to the tensioning element stretches the pouchinto its stretched state, and

the adjustment-facilitating tool is advanceable along the guide memberto the implant subsequent to implantation of the implant.

In an application, the apparatus further includes anadjustment-facilitating tool that includes a tensioning element that isreversibly couplable to the pouch, such that while coupled to the pouch,application of a proximally-directed force to the tensioning elementstretches the pouch into its stretched state.

In an application, the apparatus further includes a guide member,reversibly coupled to the implant, and the adjustment-facilitating toolis advanceable along the guide member to the implant subsequent toimplantation of the implant.

In an application, the adjustment-facilitating tool further includes apressing element, slidably coupled to the tensioning element such that,while the tensioning element is coupled to the pouch, application of adistally-directed force to the pressing element presses the pressingelement against the implant.

In an application, the pressing element maintains coupling between thetensioning element and the pouch, and withdrawal of the pressing elementdecouples the tensioning element from the pouch.

In an application, the pressing element is disposed coaxially around thetensioning element.

In an application, the tensioning element is disposed coaxially aroundthe pressing element.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against the implant body.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against the gripper.

In an application, the pressing element is slidably coupled to thetensioning element such that, while the tensioning element is coupled tothe pouch, application of the distally-directed force to the pressingelement presses the pressing element against an inner surface of thepouch.

In an application, the implant further includes a coupling that isattached to the pouch, and to which the adjustment-facilitating tool isreversibly couplable.

Various methods of using the systems and apparatuses described hereinare possible. For example, a method for use with an implant having animplant body and a pouch, can include one or more of the followingsteps:

implanting the implant in a heart of a subject; and

contracting the implant body by stretching the pouch into a stretchedstate by pulling on part of the pouch using a tensioning element.

In an application, implanting the implant includes transluminallydelivering the implant and anchoring the implant to a valve annulus ofthe heart, and contracting the implant body includes transluminallycontracting the implant.

In an application, implanting the implant includes transluminallydelivering a plurality of anchors to the implant, and sequentiallydriving the anchors through the implant body and into tissue of theheart.

In an application, the implant body can include an annuloplasty ringstructure, other annuloplasty device structure, or othercinchable/tensionable structure, and implanting the implant can includeanchoring the implant body (e.g., the annuloplasty ring structure, orother structure) to an annulus.

In an application, contracting the implant body includes stretching thepouch into the stretched state by pulling on the part of the pouch usingthe tensioning element, while simultaneously providing an opposing forcevia a pressing element that abuts the implant.

In an application, the method further includes advancing the tensioningelement to the implant subsequently to implanting the implant, and priorto contracting the implant.

In an application, advancing the tensioning element to the implantincludes advancing the tensioning element over a guide member that isreversibly coupled to the implant.

In an application, the method further includes decoupling the guidemember from the implant subsequently to advancing the tensioning elementto the implant.

In an application, the method further includes, subsequently tostretching the pouch into the stretched state, allowing the pouch toelastically contract toward a contracted state without reversing thecontraction of the implant body.

In an application, the implant includes an elongate member and agripper, the elongate member extending from the part of the pouch,though the gripper, and into the implant body, and contracting theimplant body includes drawing the elongate member through the gripperand into the pouch by stretching the pouch into the stretched state.

In an application, the method further includes, subsequently tostretching the pouch into the stretched state, allowing the pouch toelastically contract toward a contracted state without allowing theelongate member to move back out of the pouch and through the gripper.

In an application, drawing the elongate member through the gripper andinto the pouch includes drawing the elongate member through the gripperand into the pouch while maintaining the gripper in an unlocked state.

In an application, the method further includes, subsequently to drawingthe elongate member through the gripper and into the pouch,transitioning the gripper into a locked state.

In an application, transitioning the gripper into the locked stateincludes removing an unlocker from the gripper such that the gripperautomatically transitions into the locked state.

Additional components/features and additional steps described elsewhereherein can also be used in the examples above.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-C are schematic illustrations of an adjustment system, inaccordance with some applications of the invention;

FIGS. 2A-D and 3A-D are schematic illustrations of respectiveembodiments of an adjustment-facilitating tool being used with theadjustment system to adjust an implant, in accordance with someapplications of the invention;

FIGS. 4A-D are schematic illustrations of the use of a guide member toadvance the adjustment-facilitating tool to the implant, in accordancewith some applications of the invention; and

FIGS. 5, 6A-B, and 7A-B are schematic illustrations of respectiveembodiments of a gripper, in accordance with some applications of theinvention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-C, which are schematic illustrations of anadjustment system 20, in accordance with some applications of theinvention.

System 20 can comprise an implant 22 that comprises an implant body 24,and the system is for adjustment of the implant body. The implant 22and/or implant body 24 shown can take a variety of forms and thosedepicted in the various figures herein are merely exemplary. For someapplications, and as generally described herein, implant body 24 can bean annuloplasty ring structure, annuloplasty/annulus adjustmentstructure, other annuloplasty device structure, or othercinchable/tensionable structure. Implant body 24 can comprise a flexiblesleeve 25 that has a wall or circumferential wall (e.g., which can bemade of a fabric, such as a polyethylene terephthalate fabric, e.g.,Dacron™) that circumscribes a longitudinal axis of the sleeve, therebydefining a longitudinal lumen. System 20 (e.g., implant 22 thereof) canfurther comprise an elongate member 26. Elongate member 26 can compriseone or more strands of metal or polymer, optionally coated with alow-friction coating, such as polytetrafluoroethylene (PTFE). Implantbody 24 can be configured to be placed partially or completely around acardiac valve annulus 10 (e.g., a mitral valve annulus, tricuspid valveannulus, etc.). Implant body 24 can be secured or anchored in place atthe valve annulus in a variety of ways, including by suturing theimplant body 24 to the valve annulus, e.g., by parachuting similar to asurgical annuloplasty ring or otherwise. Implant body 24 can beconfigured to be anchored in place using a plurality of (e.g., 5-20)tissue anchors 32. The tissue anchors 32 can have a variety of features,for example, each tissue anchor 32 can comprise a tissue-couplingelement 34, and a tool-engaging head 36 fastened to one end of thetissue-coupling element. Following introduction of implant body 24 intothe subject, each anchor 32 can be sequentially intracorporeallydelivered into the lumen of the sleeve, and its tissue-coupling element34 can be driven from the interior lumen or from one side through thecircumferential wall and into tissue of the valve annulus, therebyanchoring the implant body 24 or sleeve to the valve annulus. After theimplant 22 and/or implant body 24 are secured or anchored to the valveannulus, longitudinal contraction of implant body 24, facilitated bysystem 20, can be used to circumferentially tighten the valve annulus,thereby improving coaptation of the valve leaflets, and reducingregurgitation.

For some applications, the implant structure of implant body 24 can be,or share features with, mutatis mutandis, any of the implant structuresdescribed in one or more of the following publications, which areincorporated herein by reference. The relevant features of the systemherein may be substituted for adjustment features in these references.For some applications, implant 22 is implanted as described in one ormore of these publications, mutatis mutandis:

-   PCT application publication WO 2010/128503 to Zipory et al.-   PCT application publication WO 2012/176195 to Gross et al.-   PCT application publication WO 2013/069019 to Sheps et al.-   PCT application publication WO 2014/064694 to Sheps et al.-   U.S. Pat. No. 8,926,696 to Miller et al.-   U.S. Pat. No. 8,353,956 to Miller et al.

FIGS. 1A-C illustrate a generalization of system 20. More specificembodiments are described with reference to later figures.

Implantable apparatus or system 20 can comprise a gripper 40 and a pouch50 (e.g., an elastic pouch) or other container. Pouch 50 can have afirst part 54 and a second part 56, and has a contracted state (seeFIGS. 1A and 1C) toward which the pouch is biased (e.g., elasticallybiased, shape-memory biased, etc.). The pouch 50 can have one ormultiple contracted states. In the contracted state, the pouch can beconfigured to define a contracted distance d1 between the first part andthe second part. Pouch 50 can be reversibly stretchable into a stretchedstate (FIG. 1B) in which the pouch defines a stretched distance d2between first part 54 and second part 56. Distance d1 is smaller thandistance d2. For example, distance d1 may be 1-12 mm (e.g., 1-7 mm, suchas 2-6 mm), whereas distance d2 may be 20-100 mm (e.g., 30-80 mm, suchas 40-70 mm).

Implantable apparatus or system 20 can also include an elongate member26 that can extend into the pouch 50. Elongate member can be arrangedsuch that it extends through a gripper 40, and then into pouch 50 via anopening 52. Opening 52 can be defined by second part 56 of the pouch. Afirst end portion 27 of elongate member 26 can be coupled to implantbody 24. A second end portion 29 of elongate member 26 can be fastenedto first part 54 of the pouch. Second part 56 can be defined by thelocation of opening 52, and first part 54 can be defined by the locationof the fastening of elongate member 26 to pouch 50.

A third portion or mid-portion 28 of elongate member 26 can be betweenend portions 27 and 29. Mid-portion or third portion 28 can extendthrough gripper 40. Gripper 40 is configured (i) to facilitatetensioning of the elongate member, and (ii) to subsequently maintain thetension on the elongate member. As described in more detail hereinbelow,gripper 40 can have at least one state in which third portion ormid-portion 28 is slidable through the gripper and into pouch 50 viaopening 52. For example, gripper 40 may facilitate one-way sliding ofportion 28 therethrough. Alternatively or additionally, gripper 40 canhave (i) an unlocked state in which it facilitates sliding of portion 28therethrough, and (ii) a locked state in which it inhibits the slidingof the third portion or mid-portion.

Implantable apparatus or system 20 can also comprise an implant 22. FIG.1A shows implant 22 subsequent to its implantation, and before itsadjustment (i.e., contraction). Pouch 50 is shown in a contracted state(e.g., relaxed state). FIG. 1B shows pouch 50 having been reversiblystretched into a stretched state. Because second end portion 29 isfastened to first part 54, this stretching pulls on elongate member 26,drawing it (e.g., third portion or mid-portion 28 thereof) throughgripper 40 and opening 52, into pouch 50, thereby longitudinallycontracting implant body 24, e.g., by reducing the length of theelongate member disposed within the implant body. For applications inwhich implant body 24 is an annuloplasty ring structure or otherannuloplasty device structure implanted around the valve annulus (e.g.,all or a portion thereof), this longitudinal contractioncircumferentially tightens the valve annulus, thereby improvingcoaptation of the valve leaflets, and reducing or eliminatingregurgitation. It is to be understood that, during this step, gripper 40can be in at least one state in which portion 28 is slidable through thegripper and into pouch 50 via opening 52. Optionally, pouch 50 andgripper 40 can be integral with or separate from implant 22. Theimplants or implant bodies described herein can have an open or closed(e.g., a closed ring) configuration and can be configured fortransvascular or transcatheter implantation and/or surgicalimplantation.

FIG. 1B does not show how pouch 50 is stretched. Some examples oftechniques for stretching pouch 50 are described in further detailhereinbelow. However, FIG. 1B does show a coupling 58 via which a toolis couplable to pouch 50 for stretching (e.g., pulling on) the pouch.For some applications, and as shown throughout this patent application,second end portion 29 of elongate member 26 can be fastened to firstpart 54 of pouch 50 by being fastened to coupling 58. The position ofcoupling 58 may thereby define or be first part 54 of pouch 50.

Subsequently, pouch 50 is allowed to return toward its contracted state(FIG. 1C), but gripper 40 can be designed or configured to inhibit orprevent elongate member 26 from sliding back through gripper 40 and intoimplant body 24. For example, and as described hereinbelow, gripper 40may only facilitate one-way movement of member 26 therethrough, or mayhave been locked subsequently to the stretching of pouch 50. Becauseelongate member 26 is inhibited or prevented from sliding back throughgripper 40, implant body 24 remains in its reduced length, and the valveannulus remains at its repaired size.

For some applications, pouch 50 can be made from or comprise anelastomer. For some applications, pouch 50 can comprise one or morestrands of elastic and/or shape memory material such as Nitinol, e.g.,optionally, threaded into the pouch so as to provide the pouch with itselastic nature.

Pouch 50 is typically distinct from an inflatable balloon. For someapplications, pouch 50 can be partially permeable, allowing blood (orcomponents thereof) to enter the pouch over time, and facilitatingclotting and/or tissue growth therein. It is believed that this mayfacilitate maintenance of the tension applied to elongate member 26, andthereby maintenance of the contraction of implant body 24.

For some applications, pouch 50 can be impermeable to blood and/orcomponents thereof. It is believed that this may facilitate readjustmentof implant 22 subsequent to its implantation and initial contraction.

While a pouch might not be used, the pouch is beneficial to contain andrestrict movement of any excess portion of the elongate member. Forexample, in the absence of pouch 50 (e.g., adjustment by pullingdirectly on end portion 29), the resulting excess 30 of elongate member26 outside of implant body 24 may disadvantageously move freely withinthe body (e.g., within left atrium 6), with potentially deleteriouseffects. The elastic return of pouch 50 to its contracted state cancompress excess 30 of elongate member 26, such that it is tidilyconfined. It is believed that this can advantageously avoid excess 30being free within the heart, while obviating a potential need to remove(e.g., by cutting) excess 30.

For some applications, pouch 50, gripper 40, and implant body 24 can becoupled together such that, from proximal end portion 29, until at leastimplant body 24, elongate member 26 is not exposed to the body of thesubject. That is, the pouch and gripper isolate the elongate member fromthe body of the subject. For some applications, more distal portions ofelongate member 26 are exposed to the body of the subject, e.g., ifelongate member 26 weaves in and out of implant body 24 (e.g., thecircumferential wall of sleeve 25).

Although system 20 is generally described herein as including implant22, it is to be noted that the scope of the invention does not requirethe system 20 to include the implant or any other component. Forexample, system 20 may be provided alone or unattached or uncombinedwith an implant, such that it can be later attached to and/or used witha different implant, e.g., a third-party implant. In one embodiment,system 20 can comprise pouch 50, gripper 40, elongate member 26, and oneor more anchors attached to the elongate member, e.g., without aseparate implant body.

Reference is made to FIGS. 2A-D and 3A-D, which are schematicillustrations of exemplary embodiments of adjustment-facilitating tool60 being used with system 20 to adjust (e.g., contract) implant 22, inaccordance with some applications of the invention. Various embodimentsof tool 60 can comprise a tensioning element 62, and/or can comprise apressing element 64.

The use of common reference numerals is intended to indicate commonalitybetween elements of different embodiments, e.g., whereby an element ofone embodiment serves the same primary function as the correspondingelement of another embodiment. Suffixes (e.g., a, b, etc.) are used touniquely identify the elements of a particular embodiment. For example,the embodiments of FIGS. 2A-D and 3A-D are depicted as each including atool 60 (tools 60 a and 60 b, respectively) that comprises a tensioningelement 62 (elements 62 a and 62 b). Despite the described differencesbetween tools 60 a and 60 b, and between elements 62 a and 62 b, bothtools are used to contract their respective implant 22, and bothtensioning elements are coupled to their respective pouch 50, and areused to apply a proximally-directed force to (i.e., to pull on) thepouch to stretch it.

FIGS. 2A-D show an exemplary embodiment in which a tool 60 a (anembodiment of tool 60) comprises a tensioning element 62 a (anembodiment of tensioning element 62) and a pressing element 64 a (anembodiment of pressing element 64), and an implant 22 a (which can bethe same as or similar to implant 22 or can be any implant that requirescinching or tightening from a remote or removed location) comprises agripper 40 a (an embodiment of gripper 40), an elastic pouch 50 a (anembodiment of pouch 50), and a coupling 58 a (an embodiment of coupling58).

For some applications, implant 22 (e.g., implant 22 a) can be deliveredand implanted while at least part of tool 60 (e.g., tool 60 a) iscoupled to the implant. For example, implant 22 a can be delivered andimplanted while (i) tensioning element 62 a is coupled to coupling 58 a,and (ii) pressing element 64 a abuts implant body 24. Alternatively,implant 22 a can be delivered and implanted while (i) tensioning element62 a is coupled to coupling 58 a, and (ii) pressing element 64 a isproximal to the implant (e.g., within a delivery catheter or outside ofthe subject), and is subsequently advanced over and along the tensioningelement to the implant. Optionally, another arrangement could also beused.

For some applications, implant 22 (e.g., implant 22 a) is delivered andimplanted without tool 60 (e.g., tool 60 b) coupled to the implant, andone or more components of the tool are subsequently advanced to theimplant (e.g., over and along a dedicated guide wire or guide member)and coupled to the implant, e.g., as described with reference to FIGS.4A-D, mutatis mutandis.

While tensioning element 62 a is coupled to coupling 58 a, thetensioning element can be pulled proximally to reversibly stretch pouch50 a. Stretching the pouch can draw elongate member 26 (e.g., portion 28thereof) through gripper 40 a and into the pouch (FIG. 2B). This can beperformed while pressing element 64 provides an opposing force againstimplant 22 (e.g., against implant body 24) in order that the pulling notpull the implant away from the tissue at which it is implanted. Pressingelement 64 a can be tubular and/or configured in a variety of shapes.Pressing element 64 a can be disposed around tensioning element 62 a(e.g., coaxially). Pressing element 64 a or at least at its distal endcan be wider than pouch 50 a, such that it can press against the implantwithout interfering with the stretching of the pouch. Optionally, thepressing element could be configured to pass to one or more sides of thepouch to contact the implant, e.g., without surrounding the pouch.

After the implant and/or implant body 24 has been sufficientlycontracted—which can be determined by imaging of the implant (e.g.,using fluoroscopy, etc.), the anatomy, and/or blood flow (e.g., usingechocardiography, ultrasound, etc.)—pouch 50 a can be allowed to returnto its contracted state (FIG. 2C). Gripper 40 a can be configured toinhibit elongate member 26 from sliding back through the gripper andinto implant body 24. For example, the gripper 40 a and/or othergrippers described herein can have friction resistance, a latch, valve,clamp, etc. that can allow movement of the member in one direction, butnot the other direction. Tool 60 a can be decoupled from implant 22 a(e.g., element 62 a can be decoupled from coupling 58 a), and withdrawnfrom the subject (FIG. 2D). For some applications, and as shown, pouch50 a is allowed to return to its contracted state by moving element 62 adistally, and/or by releasing tension on element 62 a such that theelastically-contracting pouch pulls element 62 a distally. For someapplications, pouch 50 a is allowed to return to its contracted state bydecoupling tool 60 a, including moving element 62 a, from implant 22 a,e.g., skipping the step shown in FIG. 2C.

FIGS. 3A-D show an embodiment in which a tool 60 b (an embodiment oftool 60) comprises a tensioning element 62 b (an embodiment oftensioning element 62) and a pressing element 64 b (an embodiment ofpressing element 64), and an implant 22 b (e.g., the same as or similarto implant 22, 22 a or any implant that needs to be contracted ortensioned) comprises a gripper 40 b (an embodiment of gripper 40), anelastic pouch 50 b (an embodiment of pouch 50), and a coupling 58 b (anembodiment of coupling 58).

For some applications, implant 22 b is delivered and implanted while atleast part of tool 60 b is coupled to the implant. For example, implant22 b can be delivered and implanted while tensioning element 62 b iscoupled to coupling 58 b. Optionally, implant 22 a can be delivered andimplanted while (i) pressing element 64 b is coupled to the implant(e.g., to gripper 40 b thereof), and (ii) tensioning element 62 b isproximal to the implant (e.g., within a delivery catheter or outside ofthe subject), and is subsequently advanced over and along the pressingelement to the implant.

For some applications, implant 22 b is delivered and implanted withouttool 60 b coupled to the implant, and one or more components of the toolare subsequently advanced to the implant (e.g., over and along adedicated guide wire or guide member) and coupled to the implant, e.g.,as described with reference to FIGS. 4A-D, mutatis mutandis.

While tensioning element 62 b is coupled to coupling 58 b, thetensioning element can be pulled proximally to reversibly stretch pouch50 b. Stretching pouch 50 b can draw elongate member 26 (e.g., portion28 thereof) through gripper 40 b and into the pouch (FIG. 3B). This canbe performed while pressing element 64 b provides an opposing forceagainst implant 22 b in order that the pulling not pull the implant awayfrom the tissue at which it is implanted. In contrast to the arrangementof elements 62 a and 64 a as shown in FIGS. 2A-2D, tensioning element 62b is depicted as being tubular and disposed around pressing element 64 b(e.g., coaxially). Pressing element 64 b can be configured and arrangedto extend distally from tensioning element 62 b, and through pouch 50 b,e.g., such that is abuts and presses against the inner surface of thepouch and/or against gripper 40 b, and such that it can provide theopposing force without interfering with the stretching of the pouch.Coupling 58 b can be shaped to define an opening through which pressingelement 64 b extends or can extend into pouch 50 b. When pouch 50 b isstretched, coupling 58 b can slide proximally along pressing element 64b.

After the implant 22 and/or implant body 24 has been sufficientlycontracted, pouch 50 b is allowed to return to its contracted state(FIG. 3C). Gripper 40 b can be the same as or similar to other grippersdescribed herein and can be configured to inhibit elongate member 26from sliding back through the gripper and into implant body 24. Tool 60b can be decoupled from implant 22 b (e.g., element 62 b can bedecoupled from coupling 58 b), and withdrawn from the subject (FIG. 3D).For some applications, and as shown, pouch 50 b can be allowed to returnto its contracted state by moving element 62 b distally, and/or byreleasing tension on element 62 b such that the elastically-contractingpouch pulls element 62 b distally. For some applications, pouch 50 b isallowed to return to its contracted state by decoupling tool 60 b,including element 62 b, from implant 22 b, e.g., skipping the step shownin FIG. 3C.

For some applications, pressing element 64 maintains the couplingbetween tensioning element 62 and coupling 58. For example, withreference to FIGS. 3A-D, the presence of pressing element 64 b withincoupling 58 b may hold a detent 66 defined by tensioning element 62 bwithin a recess 68 defined by coupling 58 b (or a detent defined by thecoupling within a recess defined by the tensioning element). Forexample, the pressing element and/or detent can be configured ordesigned such that, upon removal of the pressing element, the detentautomatically retracts from the recess, decoupling the tensioningelement from the coupling.

Reference is again made to FIGS. 2A-D and 3A-D. Optionally, tool 60 cancomprise an extracorporeal controller (not shown), which can comprise atleast one handle, at the proximal end of elements 62 and 64. For someapplications, the length of elongate member 26 (e.g., of portion ormid-portion 28) that slides proximally through gripper 40 and into pouch50 is proportional (e.g., equal) to the amount by which implant body 24contracts. Therefore, for some applications, the length by which implantbody 24 contracts can be proportional (e.g., equal) to the distancemoved by tensioning element 62 relative to pressing element 64. For somesuch applications, the amount of contraction of implant body 24 can beindicated by control members of the extracorporeal controller. Forexample, actuation of a control member (e.g., turning of one or moreknobs) may cause movement between elements 62 and 64, and the amountthat the control member has been actuated (e.g., the amount that the oneor more knobs have been turned) can be indicated by a dial. For example,thereby indicating the amount of relative movement between elements 62and 64, and thereby the amount of contraction of implant body 24.

Reference is now made to FIGS. 4A-D, which are schematic illustrationsof the use of a guide member 70 (e.g., which can be a guide wire orother guide) to advance adjustment-facilitating tool 60 to implant 22and/or to pouch 50, in accordance with some applications of theinvention. For some applications, the implant can be implanted withoutan adjustment tool (e.g., tool 60) coupled thereto, and the tool can besubsequently advanced to the implant in order to adjust the implant. Forsuch applications, implant 22 can be implanted with a guide member 70coupled thereto (FIG. 4A). Subsequent to implantation, tool 60 can beadvanced along (optionally over) guide member 70 (FIG. 4B), thentensioning element 62 can be coupled to pouch 50 (e.g., via coupling58). Tool 60 can then be used to adjust implant 22 (e.g., tolongitudinally contract the implant), e.g., by reversibly stretchingpouch 50 (FIG. 4C). Pouch 50 can then be allowed to return to itscontracted state, and tool 60 can be decoupled from implant 22 (FIG.4D). As shown, guide member 70 can be decoupled from implant 22subsequent to adjustment of the implant. This can be achieved by anysuitable technique, such as unscrewing, unlocking a lock, etc., and canbe performed using tool 60.

For some applications, guide member 70 is coupled to implant 22 atcoupling 58. For some applications, guide member 70 is coupled toimplant 22 at gripper 40 (e.g., as described with reference to FIGS.6A-B). For some such applications, guide member 70 extends through pouch50 to gripper 40. Other coupling options are also possible.

Reference is now made to FIGS. 5, 6A-B, and 7A-B which are schematicillustrations of exemplary embodiments of gripper 40. As describedhereinabove, gripper 40 can allow for unidirectional movement/sliding orhave at least one state in which third portion or mid-portion 28 ofelongate member 26 is slidable through the gripper and into pouch 50 viaopening 52. The gripper 40 can be configured such that the portion 28and/or elongate member 26 is not slidable from the pouch back in to theimplant. For example, gripper 40 may facilitate only one-way sliding ofportion 28 therethrough. Optionally, it is also possible to configuregripper 40 to allow movement or sliding of the portion 28 and/orelongate member 26 into and out of the gripper 40 in both directionsuntil the gripper is locked, clamped, or otherwise secured to preventmovement or sliding of the portion 28 and/or elongate member 26therethrough. For example, gripper 40 may have (i) an unlocked state inwhich it facilitates sliding of portion 28 therethrough, and (ii) alocked state in which it inhibits the sliding of theportion/mid-portion.

FIG. 5 shows an exemplary embodiment 80 of gripper 40, which has aunidirectional state in which the gripper facilitates one-way sliding ofportion 28 therethrough. Gripper 80 can comprise one or more wheels 82,each wheel comprising a gripping surface 84 (e.g., comprising aplurality of teeth or comprising other frictional element(s)) that cangrip portion 28. Wheels 82 can be configured to rotate in only onerotational direction, and thereby facilitate movement of portion 28 in afirst direction through the gripper into pouch 50, but not in a seconddirection through the gripper out of the pouch. For example, gripper 80may comprise a pawl 86 that allows rotation of wheel 82 in only onerotational direction. Optionally, the one or more wheels could beconfigured to allow rotation in both directions until locked or securedto prevent further movement.

FIGS. 6A and 6B show an exemplary embodiment 100 of gripper 40 in whichthe gripper has (i) an unlocked state in which it facilitates sliding ofportion 28 in either direction therethrough, and (ii) a locked state inwhich it inhibits the sliding of the portion in either direction.Optionally, the gripper can be biased to assume the locked state.

For some applications, gripper 100 can comprise at least one lockingelement 102 (e.g., a jaw, latch, contact edge, etc.) that, in the lockedstate, clamps onto portion 28 or elongate member 26. The jaw 102 (orother locking element) can have a gripping surface 104, such as one ormore teeth or other frictional feature(s), that frictionally engages orgrips portion 28 when the locking element or jaw contacts or clamps ontothe portion of elongate member 26.

The system can also comprise an unlocker 110, which can be configured tomaintain the gripper in an unlocked state. Optionally, gripper 100 canbe configured to automatically transition into a locked state uponremoval of unlocker 110 from the gripper. As shown, for example, inFIGS. 6A and 6B, unlocker 110 can be shaped to define a partial tubethat inhibits (e.g., obstructs) jaw 102 (or other locking element) fromclamping on to portion 28 and allows the portion to slide through thecavity defined by the partial tube. Because the unlocker defines only apartial tube, it is not threaded onto elongate member 26, and cantherefore be removed from the implant after the gripper is locked.Unlocker 110 thereby serves as an actuator of gripper 100 (e.g., of jaw102 thereof), via which the gripper is transitionable between itsunlocked and locked states.

For some applications, and as shown, unlocker 110 can be defined by, orcan be coupled to, the distal end of guide member 70. For suchapplications, guide member 70 can continue distally past coupling 58 andinto pouch 50. Optionally, unlocker 110 can be distinct from guidemember 70, and/or can be used in systems that do not include guidemember 70.

FIGS. 7A and 7B show another exemplary embodiment 120 of gripper 40 inwhich the gripper has (i) an unlocked state in which it facilitatessliding of portion 28 in either direction therethrough, and (ii) alocked state in which it inhibits the sliding of the portion in eitherdirection. Gripper 120 is typically identical to gripper 100 exceptwhere noted.

Gripper 120 is configured to be transitioned between its locked andunlocked states via an unlocker 130, which thereby serves as an actuatorof gripper 120 (e.g., of jaw 102 thereof). In contrast to unlocker 110,unlocker 130 actuates gripper 120 by pulling on jaw 102, thereby pullingthe jaw away from mid-portion 28 of elongate member 26. Unlocker 130 isreversibly coupled to jaw 102, such that when the unlocker is pulledproximally (e.g., tensioned), the jaw is opened, thereby transitioningthe gripper into its unlocked state. The gripper can be biased to assumethe locked state (e.g., in the absence of pulling by unlocker 130).

For some applications, and as shown, unlocker 130 comprises a filament(e.g., a wire or suture), and is reversibly coupled to jaw 102 by beinglooped around part of the jaw. For example, and as shown, the filamentmay be coupled to the jaw by being looped through an eyelet 122 that iscoupled to or defined by the jaw. For some such applications, both endsof the filament are disposed outside of the heart (e.g., outside of thesubject), and the unlocker is tensioned by pulling on both ends. Forsome such applications, decoupling of the unlocker from the gripper isachieved by releasing one end of the filament and pulling on the otherend of the filament, causing the released end to travel toward the jawand through the eyelet, thereby unthreading the filament from theeyelet.

For some applications, and as shown, unlocker 130 (e.g., proximalportions thereof) also serve as guide member 70, e.g., as describedhereinabove, mutatis mutandis. This may alternatively be viewed as theunlocker being defined at a distal end of the guide member.

The use of unlocker 130 allows gripper 120 to be reversibly locked(e.g., locked, unlocked, and relocked), thereby further facilitatingcontrolled contraction of the implant.

Other grippers described or shown herein can also include an unlocker,for example, gripper 80 can also have an unlocked state, and can beprovided with an unlocker that inhibits wheels 82 from engaging portion28 in one position and can be moved to another position to allow wheels82 to engage portion 28.

The gripper 40 is not limited to what has been particularly shown anddescribed hereinabove. For example, although gripping surfaces 84 and104 are both shown as comprising teeth, other gripping surfaces (e.g.,high friction surfaces) may be used. For some applications, the grippercan comprise a radially-contracting element (e.g., a helical spring)that is configured to grip the elongate member by being biased toradially contract, e.g., upon removal of an unlocker.

Grippers 40, 80, 100, and 120 etc. can be used in combination with anyof the implants described herein, mutatis mutandis. For example, gripper40 a of implant 22 a, or gripper 40 b of implant 22 b, can comprisegripper 80, 100, 120, or another gripper, mutatis mutandis. The grippersmay alternatively or additionally be used to facilitate tensioning of,and/or maintenance of tension on, elongate members of other implants,including implants that do not comprise pouch 50. Such implants includeadjustable annuloplasty bands, adjustable annuloplasty rings, andadjustable prosthetic chordae tendineae.

The present invention is not limited to what has been particularly shownand described hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description. Methods can includesteps described above in various orders and combinations. Features andcharacteristics of one embodiment can be combined or incorporated intoother embodiments.

1. Apparatus for use at a valve of a heart of a subject, the apparatuscomprising: an annuloplasty implant, configured for transluminaldelivery to the valve, and comprising: an elongate member having aproximal end, and a distal portion that includes a distal end of theelongate member; a plurality of anchors, distributed along the elongatemember, the plurality of anchors including a distal-most anchor and aproximal-most anchor; and a gripper, the elongate member extendingproximally from the proximal-most anchor and through the gripper, thegripper comprising a locking element that, in a locked state thereof,inhibits sliding of the elongate member through the gripper by clampingthe elongate member; an unlocker: disposed within the gripper such thatthe unlocker obstructs the locking element from assuming the lockedstate, and removable from the gripper by proximal pulling of theunlocker out of the gripper, the gripper being configured toautomatically assume the locked state upon removal of the unlocker fromthe gripper; and a tool, transluminally advanceable toward the gripper,and configured to tension at least the distal portion of the elongatemember by pulling the elongate member proximally through the gripperwhile the unlocker obstructs the locking element from assuming thelocked state.
 2. The apparatus according to claim 1, wherein theunlocker is shaped to define a partial tube.
 3. The apparatus accordingto claim 1, wherein: the implant further comprises a container, coupledto the gripper, and the tool is configured to, after tensioning theelongate member, release the elongate member such that a proximalportion of the elongate member, disposed proximally from the gripper, isconfined by the container.
 4. The apparatus according to claim 3,wherein the container is configured to allow blood to enter thecontainer, and to reach the proximal portion of the elongate memberdisposed therein.
 5. The apparatus according to claim 3, wherein thecontainer is a pouch.
 6. The apparatus according to claim 3, wherein:the container has a first state and a second state, and the tool isconfigured to: maintain the container in the first state, and afterreleasing the elongate member, trigger the container to transition intothe second state, the proximal portion of the elongate member confinedby the container in the second state.
 7. The apparatus according toclaim 6, wherein the tool is configured to reversibly engage thecontainer.
 8. The apparatus according to claim 6, wherein the containeris elastic, the first state is a stretched state, and the second stateis a contracted state.
 9. The apparatus according to claim 6, whereinthe container is elastically biased to assume the second state.
 10. Theapparatus according to claim 6, wherein the container comprises a shapememory material that configures the container to assume the secondstate.
 11. A method for use at a valve disposed between an atrium and aventricle of a heart of a subject, the method comprising: transluminallyadvancing an implant to the atrium; securing an elongate member of theimplant along an annulus of the valve by anchoring anchors to theannulus such that: the anchors are distributed along the elongatemember, the elongate member having a proximal end, and a distal portionthat includes a distal end of the elongate member, and the anchorsincluding a distal-most anchor and a proximal-most anchor, and theelongate member extends proximally from the proximal-most anchor andthrough a gripper of the implant, the gripper being disposed in theatrium and including a locking element that, in a locked state thereof,inhibits sliding of the elongate member through the gripper by clampingthe elongate member; subsequently to securing the elongate member,tensioning at least the distal portion of the elongate member by using atool to pull the elongate member proximally through the gripper while anunlocker is disposed within the gripper and obstructs the lockingelement from assuming the locked state; and subsequently, triggering thegripper to assume the locked state by pulling the unlocker proximallyout of the gripper.
 12. The method according to claim 11, wherein theunlocker is shaped to define a partial tube, and wherein tensioning atleast the distal portion of the elongate member comprises tensioning atleast the distal portion of the elongate member by using the tool topull the elongate member proximally through the gripper while thepartial tube is disposed within the gripper and obstructs the lockingelement from assuming the locked state.
 13. The method according toclaim 11, wherein: the implant further includes a container, coupled tothe gripper, and the method further includes, subsequently to tensioningat least the distal portion of the elongate member, releasing theelongate member such that a proximal portion of the elongate member,disposed proximally from the gripper, is confined by the container. 14.The method according to claim 13, wherein releasing the elongate membersuch that the proximal portion of the elongate member is confined by thecontainer, comprises releasing the elongate member such that theproximal portion of the elongate member is confined by the container ina manner that allows blood to enter the container and reach the proximalportion of the elongate member disposed therein.
 15. The methodaccording to claim 13, wherein the container is a pouch, and whereinreleasing the elongate member such that the proximal portion of theelongate member is confined by the container, comprises releasing theelongate member such that the proximal portion of the elongate member isconfined by the pouch.
 16. The method according to claim 13, wherein:the container has a first state and a second state, tensioning at leastthe distal portion of the elongate member comprises tensioning at leastthe distal portion of the elongate member while the tool maintains thecontainer in the first state, and releasing the elongate membercomprises releasing the elongate member such that the containertransitions into the second state, the proximal portion of the elongatemember being confined by the container in the second state.
 17. Themethod according to claim 16, wherein: the container is elastic; thefirst state is a stretched state, and tensioning at least the distalportion of the elongate member while the tool maintains the container inthe first state comprises tensioning at least the distal portion of theelongate member while the tool maintains the container in the stretchedstate; and the second state is a contracted state, and releasing theelongate member such that the container transitions into the secondstate comprises releasing the elongate member such that the containertransitions into the contracted state.
 18. The method according to claim16, wherein: the container is elastically biased to assume the secondstate, and releasing the elongate member comprises releasing theelongate member such that the elastic bias of the container transitionsthe container into the second state.
 19. The method according to claim16, wherein: the container comprises a shape memory material thatconfigures the container to assume the second state, and releasing theelongate member comprises releasing the elongate member such that theshape memory material transitions the container into the second state.